Events

Retiro De Equipo (Recall) de Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Vital Diagnostics, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66202
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0732-2014
  • Fecha de inicio del evento
    2013-08-29
  • Fecha de publicación del evento
    2014-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121742
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Azo dye, calcium - Product Code CJY
  • Causa
    High positive calcium bias on plasma sample versus results on serum.
  • Acción
    Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instructed to discard the insert packed with the product and replace it with the insert enclosed with this bulletin. If product was transferred to another location, the bulletin should be forwarded to that location. The package insert was revised indicating to only use Serum samples when running Calcium. Vital Diagnostics issued a revised (expanded) notice dated September 19, 2013, to include the Consult Diagnostics¿ Eon Calcium Reagent (PN: 1429) requesting users to discontinue using the single vial Eon Calcium kit (PN: 1429). Customers with questions were instructed to call Vital Diagnostics Technical Support at 1-855-354-8324.. For questions regarding this recall call 401-642-8400.

Device

Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. || PN 55285 || For the quantitative measurement of calcium in plasma and serum
  • Manufacturer
    Vital Diagnostics, Inc.

Manufacturer

Vital Diagnostics, Inc.
  • Dirección del fabricante
    Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
  • Empresa matriz del fabricante (2017)
    Ergon Capital Partners
  • Source
    USFDA